This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
| Device | Alinity m CMV |
| Generic Name | Cytomegalovirus (cmv) Dna Quantitative Assay |
| Applicant | Abbott Molecular, Inc.1300 E. Touhy Avenuedes Plaines, IL 60018 PMA NumberP210022 Supplement NumberS002 Date Received11/03/2022 Decision Date11/28/2022 Product Code PAB Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-11-03 |
| Decision Date | 2022-11-28 |
| PMA | P210022 |
| Supplement | S002 |
| Product Code | PAB |
| Advisory Committee | Microbiology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Abbott Molecular, Inc. 1300 E. Touhy Avenue des Plaines, IL 60018 PMA NumberP210022 Supplement NumberS002 Date Received11/03/2022 Decision Date11/28/2022 Product Code PAB Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement to Implement A Large-scale Manufacturing Process For The Alinity M CMV AMP Tray 1 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P210022 | Original Filing | |
| S002 | 2022-11-03 | 30-day Notice |
| S001 | 2022-05-18 | 30-day Notice |
| Device ID | PMA | Supp |
|---|---|---|
| 00884999049956 | P210022 | 000 |
| 00884999049611 | P210022 | 000 |
| 00884999049604 | P210022 | 000 |
| 00884999049598 | P210022 | 000 |